for people ages 2-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion



This study is designed to evaluate how the body processes and removes mirikizumab. The study will also evaluate safety and disease response in pediatric participants with UC taking mirikizumab. The study will last about 52 weeks and may include up to 18 visits.

Official Title

Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis


Ulcerative Colitis, Interleukin-23 (IL-23) antibody, IL-23p19, Pediatric, Colitis, Ulcer, Mirikizumab


You can join if…

Open to people ages 2-17

  • Participants weighing >10 kg
  • Participants must have a diagnosis of ulcerative colitis for at least 3 months before the planned start date for the study medications
  • Participants must have moderately to severely active UC as defined by a Modified Mayo Score (MMS) within 14 days before the first dose of study treatment
  • Participants must have evidence of UC extending proximal to the rectum
  • Participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor (JAK-inhibitor) or to biologic therapies for UC

You CAN'T join if...

  • Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary sclerosing cholangitis
  • Participants must not have had surgery to remove part of their colon
  • Participants must not have current evidence of toxic megacolon
  • Participants must not have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 1 week of screening endoscopy
  • Participants must not have had an inadequate response to Interleukin 12 p40 subunit antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)


  • UCSF Medical Center at Mission Bay
    San Francisco California 94158 United States
  • Childrens Hospital of Orange County
    Orange California 92868 United States


in progress, not accepting new patients
Start Date
Completion Date
Eli Lilly and Company
Phase 2 research study
Study Type
Expecting 30 study participants
Last Updated